Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2)
K241612 is the FDA 510(k) clearance record for Video Bronchoscope System; Single-use Flexible Bronchoscope (BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2), a class II device, cleared for Hunan Vathin Medical Instrument Co., Ltd. on under FDA product code EOQ (Bronchoscope (Flexible Or Rigid)). FDA's definition for product code EOQ reads: "A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. If the...". FDA records list 17 510(k) clearances for Hunan Vathin Medical Instrument Co., Ltd., from to . As of , FDA records show no recalls naming K241612.
Clearance record
- Decision date
- Received
- (146 days to decision)
- Product code
- EOQ Bronchoscope (Flexible Or Rigid)
- Regulation
- 21 CFR 874.4680
- Device class
- Class II
- Review panel
- Ear, Nose, Throat
- Applicant
- Hunan Vathin Medical Instrument Co., Ltd. 1/F, Bldg. 12, Innovation And Entrepreneurship Service Ce, Xiangtan, CN
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code EOQ
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 2 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 2 |
| May 2026 | 1 |
| June 2026 | 1 |
| July 2026 | 2 |
| August 2026 | 0 |
| September 2026 | 3 |
| October 2026 | 0 |
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